BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM

    MDR report key: 1881977 · Received October 12, 2010

    Report

    Report Number
    9612186-2010-00006
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    PMA / PMN Number
    K092083
    Removal / Correction Number
    9612186-092710-016-C 806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTION: ELEKTA INSTRUMENTS AB ISSUED AN IMPORTANT NOTICE (B)(4) "POTENTIAL FAILURE OF THE EXTEND MOUTHPIECE" TO AFFECTED USERS INSTRUCTING THEM THE RETURN THE OLD MOUTHPIECES TO ELEKTA INSTRUMENTS AB WHICH WILL BE REPLACED WITH NEW MOUTHPIECES. THE CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED WITHIN THE IMPORTANT NOTICE (B)(4) AND FCO (B)(4). NO ADVERSE EVENTS ASSOCIATED WITH THIS PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    WHILE PREPARING A MOUTHPIECE FOR DENTAL IMPRESSION, IT WAS NOTED THAT THE MOUTHPIECE WAS BROKEN. WHEN INSPECTING OTHER MOUTHPIECES, FIVE WERE NOTED TO BE BROKEN. MOUTHPIECES TO BE REPLACED AT NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1